Investigation of Factors and interventions associated with good and poor recruitment to multi-centre trials (STEPS)



The randomised controlled trial is widely accepted as the gold standard design for evaluating healthcare interventions. A commonly reported problem with the conduct of multi-centre trials, however, is that recruitment is slower or more difficult than expected, with many trials failing to reach their planned sample size. The aim of the STEPS (Strategies for Trials Enrolment and Participation) study was to examine the factors that influence recruitment to randomised trials - particularly the participation of clinicians and collaborating researchers. It had three distinct components: an epidemiological review of a cohort of multi-centre trials funded by the MRC and the NHS HTA programme; case studies of trials which appeared to have particularly interesting lessons for recruitment; and a single in-depth case study to assess the feasibility of applying business theory to trial recruitment.


Alison McDonald;




MK Campbell, C Snowdon, D Francis, D Elbourne, AM McDonald, R Knight, V Entwistle, J Garcia, I Roberts and A Grant.   Recruitment to randomised trials: strategies for trial enrolment and participation study (the STEPS study). Health Technology Assessment 2007; Vol 11: number 48

David Francis, Ian Roberts, Diana R Elbourne, Haleema Shakur, Rosemary C Knight, Jo Garcia, Claire Snowdon, Vikki A Entwistle, Alison M McDonald, Adrian M Grant and Marion K Campbell.  Marketing and clinical trials: a case study. Trials 2007, 8:37 (20 Nov 2007)

Claire Snowdon, Diana R Elbourne, Jo Garcia, Marion K Campbell, Vikki A Entwistle, David Francis, Adrian M Grant, Rosemary C Knight, Alison M McDonald, Ian Roberts.   Financial considerations in the conduct of multicentre randomised controlled trials: evidence from a qualitative study. Trials 2006, 7:34 (21 December 2006)

McDonald A, Knight R, Campbell MK, Entwistle V, Grant AM, Cook JA and the STEPS Group.   What influences recruitment to randomised controlled trials?   A review of trials funded by two UK funding agencies.   Trials 2006, 7:9 (7 April 2006)